(69 days)
K# 801036, K# 955556
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
Explanation: The device, Crosstex® Surgical Masks, is intended for infection control by minimizing contamination from microorganisms and reducing exposure to bodily fluids. It is not designed to treat a disease, injury, or condition.
No
The device is a surgical mask intended for infection control and protection from fluids, not for diagnosing medical conditions.
No
The device description clearly outlines the physical components of surgical masks, including materials like polypropylene, elastic loops, aluminum wire, and a vapor barrier. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for "infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids." This describes a barrier function for personal protection, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details the physical construction of the masks and the materials used. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic tests.
- Performance Studies: The performance studies listed (Fluid Resistance, BFE, Flammability, Latex Particle Challenge, Biocompatibility) are all tests related to the physical and protective properties of a mask, not the analytical or clinical performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the Crosstex® Surgical Masks described are medical devices intended for personal protection and infection control, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
- Crosstex® Isolite® Earloop Face Masks Blue, Pink .
- Crosstex® Isofluid® Earloop Face Masks Blue, Pink, White, Green .
- Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach .
- Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach ●
- . Crosstex® Procedural Earloop Face Masks - Blue, Pink, Yellow
- Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue .
- Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor Blue ●
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The seven (7) Crosstex® Surgical Masks are constructed of either an inner/outer facing of tissue or 100% spunbonded polypropylene, a 100% meltblown polypropylene filter media, with white elastic loops and/or a fogfree strip. The nose piece for all seven (7) Crosstex® Surgical Masks is 27 gauge aluminum wire, some have an anti-fog strip, with the Crosstex® Ultra Fluid Resistant No Fog® having a vapor barrier. All of the materials used in the construction of the Crosstex® Surgical Masks are being used in currently marketed devices (see predicate information).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
- a. Fluid Resistance: Liquid (Water) Resistance Test/Impact Penetration Test
- b. Bacterial Filtration Efficiency (BFE) / Differential Pressure (△P) Tests
- c. Flammability Testing
- d. Latex Particle Challenge Test
- Biocompatibility Testing Per ISO 10993 e.
It was our conclusion that Performance Testing met all relevant requirements of the aforementioned test standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K# 801036, K# 955556
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
OCT 1 6 2008
Image /page/0/Picture/1 description: The image contains a handwritten word, "Korados". The letters are written in a cursive style, with some variations in thickness. The word appears to be written on a white background.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
1. Submitter's Identification:
Crosstex International, Inc. 10 Ranick Road Hauppauge, New York 11788 Tel No .: 631-582-6777 Fax No.: 631-582-1726
Contact Person:
Mr. Gary Steinberg President Crosstex International, Inc. 10 Ranick Road Hauppauge, New York 11788 Tel No .: 631-582-6777 Fax No .: 631-582-1726
Date Summary Prepared: July 1, 2008
2. Name of Device:
.
- . Crosstex® Isolite® Earloop Face Masks - Blue, Pink
- � Crosstex® Isofluid® Earloop Face Masks – Blue, Pink, White, Green
- Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach ●
- . Crosstex® Isofluid FogFree® Face Masks with Splash Visor - Blue, Peach
- . Crosstex® Procedural Earloop Face Masks - Blue, Pink, Yellow
- Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue
- . Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor -Bluc
3. Predicate Device Information:
- a. American Threshold Industries, Surgical Masks, K# 801036, Asheville, North Carolina.
- b. American Threshold Industries, Fluid Resistant Masks, K# 955556, Enka, North Carolina.
1
4. Device Description:
The seven (7) Crosstex® Surgical Masks are constructed of either an inner/outer facing of tissue or 100% spunbonded polypropylene, a 100% meltblown polypropylene filter media, with white elastic loops and/or a fogfree strip. The nose piece for all seven (7) Crosstex® Surgical Masks is 27 gauge aluminum wire, some have an anti-fog strip, with the Crosstex® Ultra Fluid Resistant No Fog® having a vapor barrier. All of the materials used in the construction of the Crosstex® Surgical Masks are being used in currently marketed devices (see predicate information).
5. Intended Use:
The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
- Crosstex® Isolite® Earloop Face Masks Blue, Pink .
- Crosstex® Isofluid® Earloop Face Masks Blue, Pink, White, Green ●
- . Crosstex® Isofluid FogFree® Earloop Face Masks - Blue, Peach
- . Crosstex® Isofluid FogFree® Face Masks with Splash Visor -- Blue, Peach
- . Crosstex® Procedural Earloop Face Masks - Blue, Pink, Yellow
- Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue .
- . Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor -Blue
6. Comparison to Predicate Devices:
See Attached
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
- a. Fluid Resistance:
- Liquid (Water) Resistance Test/Impact Penetration Test
- b. Bacterial Filtration Efficiency (BFE) / Differential Pressure (△P) Tests
- c. Flammability Testing
- d. Latex Particle Challenge Test
- Biocompatibility Testing Per ISO 10993 e.
It was our conclusion that Performance Testing met all relevant requirements of the aforementioned test standards.
2
8. Discussion of Clinical Test Performed:
Not Applicable
9. Conclusions:
The Crosstex® Surgical Masks have the same intended use and technological characteristics as the predicate devices. Moreover, bench testing contained in this submission supplied demonstrates that the technological characteristics do no raise any new questions of safety or effectiveness. The Crosstex® Surgical Masks are substantially equivalent to the predicate device.
3
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2008
Crosstex International, Incorporated Mr. Richard M. Ormsbee Senior Regulatory Affairs Specialist Minntech Corporation 14605 28th Avenue North Minneapolis, Minnesota 55447-4822
Re: K082258
Trade/Device Name: Crosstex® Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: September 17, 2008 Received: September 18, 2008
Dear Mr. Ormsbee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Ormsbee
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CBR
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K082258
Device Name: Crosstex® Surgical Masks
Indications for Use:
The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
- Crosstex® Isolite® Earloop Face Masks Blue, Pink .
- Crosstex® Isofluid® Earloop Face Masks Blue, Pink, White, Green .
- Crosstex® Isofluid FogFree® Earloop Face Masks Blue, Peach .
- Crosstex® Isofluid FogFree® Face Masks with Splash Visor Blue, Peach ●
- . Crosstex® Procedural Earloop Face Masks - Blue, Pink, Yellow
- Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks Blue .
- Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor Blue ●
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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